FDA UDI
In Commercial Distribution
🇺🇸 United States
SCHILLER
DI: 07613365900132
·
Model: SpO2 HQ sensor, multi-application site, 10m for MLS.
·
SCHILLER MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SCHILLER
- Primary DI
- 07613365900132
- Version / Model
- SpO2 HQ sensor, multi-application site, 10m for MLS.
- Catalog Number
- 0-13-0049
- Company Name
- SCHILLER MEDICAL
- Labeler DUNS
- 264351388
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-10
- Public Version
- 4
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- c7193452-23a8-4180-8267-68d8fdece821
Device Description
SpO2 sensor for MAGLIFE Serenity
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37808 | Pulse oximeter probe, reusable | A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613365900132 | GS1 |
Customer Contacts
- Phone
- +33388633600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023195 | 000 |